Pipeline

A unique understanding of time-dependent biological processes informs everything we innovate for the treatment of chronic neurologic disorders. We continue to search for time-dependent patterns in diseases to reshape medicines and drive improved clinical outcomes for people in need.

Our medicines are timed for the benefit of patients.

ADS-5102 (amantadine) extended-release capsules

Multiple Sclerosis: Walking Impairment

Multiple sclerosis (MS) is a chronic autoimmune-mediated disorder that affects approximately 400,000 people in the United States.1 Walking impairment is a central feature of MS progression.2,3,4 The reported prevalence of impaired mobility due to MS ranges from 50% to over 90% of patients.1 As also reported in Parkinson’s disease, dysregulation of the NMDA receptor has been associated with the symptomology of MS,5 therefore symptoms may be improved by modulating overactivated NMDA receptor signaling. In addition, the impact of walking impairment and related symptoms (eg, fatigue, depression, and cognition) is most profound during the daytime when MS patients are engaged in activities of daily living.6,7 As a result, an effective treatment should provide relief beginning in the morning, and be sustained throughout the day, while not disrupting sleep.

ADS-5102, a high-dose amantadine investigational agent taken once-daily at bedtime, was designed to provide a slow initial rate-of-rise in drug concentrations and a delayed time to the maximum concentration.

We completed a Phase 2 proof-of-concept study evaluating ADS-5102 in patients with MS who have walking impairment. In the study, patients treated with ADS-5102 showed a significant improvement in walking speed as assessed by the Timed 25 Foot Walk (T25FW) test and an improvement in the Timed Up and Go (TUG). In addition, ADS-5102 was generally well tolerated.

Based on the positive Phase 2 data, we’ve initiated the first Phase 3 study in MS patients with walking impairment in April. Our Phase 3 program is planned to consist of two Phase 3 studies, a pivotal efficacy and safety study, and an open label safety study. We are also completing non-clinical studies to support the approval in this multiple sclerosis population. If the first pivotal Phase 3 study is successful, we intend to meet with the FDA to confirm the filing requirements for this supplemental NDA.

ADS-5102 References: 1. Sutliff, M. H. Contribution of impaired mobility to patient burden in multiple sclerosis. Curr Med Res Opin; 2010 26(1): 109-119. 2. Kurtzke, J. F. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS) and Form. Neurology; 1983 33(11):1444-1452. 3. Cohen, R. A., H. R. Kessler, et al. The Extended Disability Status Scale (EDSS) as a predictor of impairments of functional activities of daily living in multiple sclerosis. J Neurol Sci; 1993 115(2):132-135. 4. Hobart, J. C., A. Riazi, et al. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology; 2003 60(1):31-36. 5. Rossi, S., V. Studer, et al. Opposite roles of NMDA receptors in relapsing and primary progressive multiple sclerosis. PLoS One; 2013 8(6):e67357. 6. Cohen, R.A., and M. Fisher. Amantadine Treatment of Fatigue Associated with Multiple Sclerosis. Arch Neurol; 1989; 46:676-680. 7. Socie, M.J., et. al. Gait variability and disability in multiple sclerosis. Gait & Posture; 2013 38:1-55.

ADS-4101 (lacosamide)
modified-release capsules

Epilepsy: Partial-onset Seizures

Epilepsy affects an estimated 2.2 million Americans, of which 60% have partial onset seizures.1,2 Monotherapy treatment of partial seizures is effective in approximately 60% of patients, leaving the remainder of patients to require adjunctive treatment with one or more additional anticonvulsant therapies.3,4 There are limited data on the temporal distribution of seizures over the 24-hour day, however, published studies suggest that seizures occur in a diurnal pattern, characterized by a peak between 8 AM and 4 PM, and lowest between midnight and 8 AM.5 Thus, by matching the timing pattern of seizures to the concentration of the anti-epileptic drug, with a higher drug concentration during the day and lower drug concentration during the night, may enable improved seizure control.

Clinical studies of lacosamide, an anti-epilepsy active ingredient previously approved by the U.S. Food and Drug Administration (FDA) and currently marketed by UCB, Inc. as VIMPAT® (lacosamide), have reported dose limitations due to dizziness immediately following administration.6 We hypothesized the dizziness associated with higher doses might be in part attributed to the rapid initial rate-of-rise in drug concentration. Adamas scientists confirmed this time-dependent effect through in vivo modeling and preclinical experiments, showing that tolerability was dependent on rate-of-rise of drug concentration and not on maximum concentrations (Cmax).

ADS-4101, a high-dose lacosamide investigational agent taken once-daily at bedtime, was designed to have a slow initial rate-of-rise in lacosamide concentrations, to potentially improve the adverse event profile. This slow initial rise may enable a higher once-daily bedtime dose, potentially resulting in a higher daytime concentration than VIMPAT.

We have completed two Phase 1 studies of ADS-4101 in healthy volunteers. The Phase 1a study showed that a single 400 mg dose of ADS-4101 was better tolerated compared to the equivalent dose of VIMPAT immediate release tablets. The data also demonstrated that ADS-4101 exhibited the desired pharmacokinetic properties, namely a reduced rate of initial rise and delayed time to maximum drug concentration appropriate for bedtime dosing. The recently completed and reported results of a multi-dose Phase 1b study demonstrated that a 600mg dose of ADS-4101, taken once-nightly, provided a 1.5 to 2.5-fold increase in average lacosamide concentrations throughout the day compared to the maximum approved daily dose of 400 mg, taken as 200 mg twice-daily (BID), of VIMPAT immediate release tablets in healthy volunteers, with comparable tolerability.

ADS-4101 References: 1. Hirtz, D., Thurman, DJ., et al. How common are the “common” neurological disorders? Neurology; 2007 68:326-337. 2. Tellez-Zenteno, JF., Ronquillo LH., et al. Discontinuation of antiepileptic drugs after successful epilepsy surgery. Epilepsy Res; 2012 102(1-2):23-33. 3. Kwan, P. B., M. J. Early identification of refractory epilepsy. N Engl J Med; 2000 42(5):314-319. 4. Brodie, M. J., S. J. Barry, et al. Patterns of treatment response in newly diagnosed epilepsy. Neurology; 2012 78(20):1548-1554. 5. Hofstra, W. A., B. E. Grootemarsink, et al. Temporal distribution of clinical seizures over the 24-h day: a retrospective observational study in a tertiary epilepsy clinic. Epilepsia; 2009 50(9):2019-2026. 6. Horstmann, R., R. Bonn, et al. Basic Clinical Pharmacologic Investigations of the New Antiepileptic Drug SPM 927. Epilepsia; 2002 43(S7).

Clinical Program Director

The Clinical Program Director plays a critical role in developing and managing the clinical operations team and infrastructure for a given project(s). This position will provide strategic and operational leadership and drive the planning and execution for assigned clinical trials with direct responsibility for time, cost, quality and risk mitigation. This position is based in Emeryville, CA and reports to the Vice President, Clinical Operations.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director, Publications and Scientific Communications

The Director, Publications and Scientific Communications, is responsible for all the R&D deliverables: including the scientific platform and its derivatives: abstracts, posters, manuscripts, and other collateral (e.g., videos, master slide decks). This position reports to the Vice President, Research and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director, Regulatory Affairs Development

The Director, Development Regulatory Affairs ensures that regulatory expertise is provided for all investigational drug development programs to enable product registration. The incumbent will be an effective collaborator with the research, clinical research, clinical operations, pharmaceutical development, and quality departments. This position reports to the Vice President, Regulatory Affairs and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Medical Science Liaison / Sr. Medical Science Liaison - Dallas, TX

The Medical Science Liaison is responsible for conducting medical/scientific interactions and for supporting internal activities related to medical communications, medical information and clinical research. This position reports to the Director, MSL Team and is field based with a corporate headquarters in Emeryville, California.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Medical Science Liaison / Sr. Medical Science Liaison - Philadelphia, PA

The Medical Science Liaison is responsible for conducting medical/scientific interactions and for supporting internal activities related to medical communications, medical information and clinical research. This position reports to the Director, MSL Team and is field based with a corporate headquarters in Emeryville, California.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Clinical Research Associate

The Senior Clinical Research Associate (Sr. CRA) will be responsible for ensuring high quality execution of single and multi-site clinical studies, across all Phases, according to the protocols, while adhering to GCP/ICH, and to Adamas Pharmaceutical Inc. SOPs within reasonable limits of time and budget. Reports to the Director, Clinical Operations.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Counsel, Healthcare Law

The Senior Counsel, Healthcare Law, will support legal matters related to the strategy and execution of commercial, medical, and clinical activities. This position reports to the Assistant General Counsel and is expected to work closely with other members of the legal and compliance group, as well as executive, commercial, medical, regulatory, and clinical teams. This position is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Manager, Pre-commercial Quality Assurance

The Senior Manager, Pre-commercial Quality Assurance is responsible for managing quality operations at Adamas Contract Service Providers of clinical drug substance, drug product, packagers and distribution to ensure that CSP are in compliance with applicable regulations, Quality Agreements (QA), and Standard Operating Procedures (SOP’s). In addition will provide Quality support to all Development Project Teams. This position will report to the Vice President of Quality Assurance and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.